CRA专业术语中英文对照.doc

缩略语 英文全称 中文全称ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者BMI Body Mass Index 体质指数CI Co-investigator 合作研究者COI Coordinating Investigator 协调研究者CRA Clinical Research Associate 临床监查员（临床监察员）CRC Clinical Research Coordinator 临床研究协调者CRF Case Report Form 病历报告表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application 临床研究申请CSA Clinical Study Agreement 临床研究协议CTA Clinical Trial Application 临床试验申请CTX Clinical Trial Exemption 临床试验免责CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统FA Financial Agreement 财务协议FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GLP Good Laboratory Practice 药物非临床试验质量管理规范GMP Good Manufacturing Practice 药品生产质量管理规范IB Investigators Brochure 研究者手册IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所（美国）PI Principal Investigator 主要研究者PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可（申请）PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SI Sub-investigator 助理研究者SI Sponsor-Investigator 申办研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO国际药品管理当局会议Active Control 阳性对照、活性对照 Audit 稽查 Audit Report 稽查报告 Auditor 稽查员 Blank Control 空白对照 Blinding/masking 盲法/设盲 Case History 病历 Clinical study 临床研究 Clinical Trial 临床试验 Clinical Trial Report 临床试验报告 Compliance 依从性 Coordinating Committee 协调委员会 Cross-over Study 交叉研究 Double Blinding 双盲 Endpoint Criteria/measurement 终点指标 Essential Documentation 必需文件 Exclusion Criteria 排除标准 Inclusion Criteria 入选表准 Information Gathering 信息收集 Initial Meeting 启动会议 Inspection 检察/视察 Institution Inspection 机构检察 Investigational Product 试验药物 Investigator 研究者 Monitor 监查员（监察员） Monitoring 监查（监察） Monitoring Plan 监查计划（监察计划） Monitoring Report 监查报告（监察报告） Multi-center Trial 多中心试验 Non-clinical Study 非临床研究 Original Medical Record 原始医疗记录 Outcome Assessment 结果评价 Patient File 病人档案 Patient History 病历 Placebo 安慰剂 Placebo Control 安慰剂对照 Preclinical Study 临床前研究 Protocol 试验方案 Protocol Amendments 修正案 Randomization 随机 Reference Product 参比制剂 Sample Size 样本量、样本大小 Seriousness 严重性 Severity 严重程度 Single Blinding 单盲 Sponsor 申办者 Study Audit 研究稽查 Subject 受试者 Subject Enrollment 受试者入选 Subject Enrollment Log 受试者入选表 Subject Identification Code List 受试者识别代码表 Subject Recruitment 受试者招募 Study Site 研究中心 Subject Screening Log 受试者筛选表 System Audit 系统稽查 Test Product 受试制剂 Trial Initial Meeting 试验启动会议 Trial Master File 试验总档案 Trial Objective 试验目的 Triple Blinding 三盲 Wash-out 洗脱 Wash-out Period 洗脱期Position: Clinical Research Associate Location: Beijing, Shanghai, Guangzhou, Wuhan, Chengdu, Shengshang Responsibilities: 1. To ensure protocol compliance, ICH-GCP and other regulatory obligations at trial sites by standardized monitoring activities 2. Verifies the accuracy and authenticity of clinical data, manage investigational products and other trial related supplies, maintain adequate clinical trial documentation etc 3. Ensure site activities in line with milestones (i.e. start-up, monitoring, closeout, etc.) in compliance with protocol, SOPs and ICH-GCP 4. Ensure a good communication between sponsor and investigator, report related issues to the line manager immediately 5. To ensure the timely reporting of study information, which includes safety reporting to relevant study team member and regulatory authorities 6. Other issues related to clinical trial monitoring Qualifications: 1. Bachelor or above in medical or above, majoring in medicine or pharmacy or relat